Decitabine Combining Modified CAG Followed by HLA Haploidentical Peripheral Blood Mononuclear Cells Infusion for Elderly Patients With Intermediate-high Risk Myelodysplastic Syndrome(MDS) or Acute Myeloid Leukemia(AML)
This study is currently recruiting participants.
Verified January 2013 by Chinese PLA General Hospital
Sponsor:
Chinese PLA General Hospital
Collaborator:
Navy General Hospital, Beijing
Information provided by (Responsible Party):
Li Yu, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01690507
First received: September 19, 2012
Last updated: January 30, 2013
Last verified: January 2013
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Purpose
Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory molecules and adhesion molecules. The leukemias cells treated by decitabine will become more sensitive to the following adoptive T cell therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
MDS AML |
Drug: Decitabine Drug: Cytarabine Drug: aclacinomycin Drug: Granulocyte colony-stimulating factor Other: HLA haploidentical mononuclear cells infusion |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1/2 Study of Decitabine Combined With Modified CAG Followed by HLA Haploidentical T Cell Infusion in Treating Elderly Patients With Intermediate-high Risk Myelodysplastic Syndrome(MDS) or Acute Myeloid Leukemia(AML) |
Resource links provided by NLM:
Drug Information available for:
Cytarabine
Decitabine
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by Chinese PLA General Hospital:
Primary Outcome Measures:
- overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- event free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- complete remission rate [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- overall response rate [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DCAG plus DLI
Patient will be treated with decitabine and modified CAG regimen followed by HLA haploidentical peripheral mononuclear blood cells infusion
|
Drug: Decitabine
20 mg/m²/day for 5 days
Drug: Cytarabine
Drug: aclacinomycin
Drug: Granulocyte colony-stimulating factor
Other Name: G-CSF
Other: HLA haploidentical mononuclear cells infusion
Other Name: DLI
|
|
Active Comparator: DCAG
Patients will be treated with decitabine and modified CAG regimen
|
Drug: Decitabine
20 mg/m²/day for 5 days
Drug: Cytarabine
Drug: aclacinomycin
Drug: Granulocyte colony-stimulating factor
Other Name: G-CSF
|
Eligibility| Ages Eligible for Study: | 60 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
PATIENT Inclusion Criteria:
- Must have a diagnosis of MDS-RAEB or AML based on 2008 World Health Organization (WHO) classification of myeloid malignancies
- Must have life expectancy >= 3 months
- Must have the ability to observe the efficacy and events
- Must have no accompany therapy(including steroid)
- Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 3
- Must have haploidentical donor
DONOR Inclusion Criteria:
- Must have signed the standard informed consent form; if sufficient cryopreserved cells remain from a previous donation, no additional donation or consent is required
- Both men and women and members of all races and ethnic groups are eligible for this trial
PATIENT Exclusion Criteria:
- Must not have an advanced malignant hepatic tumor
- Must not receive any other forms of chemotherapy after cell infusion during the treatment protocol
- Must not be receiving any other investigational agents within 14 days of first dose of study drug
- Must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Must not be pregnant or breastfeeding; pregnant women are excluded from this study because decitabine is a Category D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine; these potential risks may also apply to other agents used in this study
- Must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or other agents used in the study
- Must not have a known or suspected hypersensitivity to decitabine
- Must not be human immunodeficiency virus (HIV)-positive and on combination antiretroviral therapy; these patients are ineligible because of the potential for pharmacokinetic interactions with decitabine; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
DONOR Exclusion Criteria:
- Must not have any underlying conditions which would contra-indicate apheresis
- Must not be pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690507
Contacts
| Contact: Li Yu, M.D. Ph.D. | 86-010-55499003 | chunhuiliyu@yahoo.com |
| Contact: Li-Xin Wang, M.D. Ph.D. | 86-010-66958509 | wanglixin1991@sohu.com |
Locations
| China, Beijing | |
| Navy General Hospital | Recruiting |
| Beijing, Beijing, China, 100048 | |
| Contact: Li-Xin Wang, M.D Ph.D 86-010-66958509 wanglixin1991@sohu.com | |
| Principal Investigator: Li-Xin Wang, M.D. Ph.D. | |
| China | |
| Chinese PLA General Hospital | Recruiting |
| Beijing, China, 100853 | |
| Contact: Li Yu, M.D. Ph.D. 86-010-55499003 chunhuiliyu@yahoo.com | |
| Principal Investigator: Li Yu, M.D. Ph.D. | |
Sponsors and Collaborators
Chinese PLA General Hospital
Navy General Hospital, Beijing
Investigators
| Principal Investigator: | Li Yu, M.D. Ph.D. | Chinese PLA General Hospital |
More Information
No publications provided
| Responsible Party: | Li Yu, Director of Department of Hematology and BMT Center, Chinese PLA General Hospital |
| ClinicalTrials.gov Identifier: | NCT01690507 History of Changes |
| Other Study ID Numbers: | CN301-XYK-001 |
| Study First Received: | September 19, 2012 |
| Last Updated: | January 30, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Chinese PLA General Hospital:
|
demethylating agent immunogenicity |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Cytarabine Decitabine Aclacinomycins Lenograstim |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Enzyme Inhibitors Adjuvants, Immunologic Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on May 16, 2013